OncoMatch/Clinical Trials/NCT04240054
Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency
Is NCT04240054 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Bortezomib and Isatuximab for multiple myeloma.
Treatment: Bortezomib · Isatuximab · Cyclophosphamide · Dexamethasone — This is a single-arm, open-label phase II study with a safety lead-in phase.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: multiple myeloma-directed therapy
Exception: dexamethasone (up to 160 mg), bortezomib (up to 5.2 mg/m^2), and/or cyclophosphamide up to 500 mg/m^2 administered for management of acute manifestations of MM for no longer than four weeks prior to enrollment
No prior multiple myeloma (MM) -directed therapy except for dexamethasone (up to 160 mg), bortezomib (up to 5.2 mg/m^2) and/or cyclophosphamide up to 500 mg/m^2 administered for management of acute manifestations of MM (hypercalcemia, renal impairment, pain) for no longer than four weeks prior to enrollment.
Lab requirements
Blood counts
Absolute neutrophil count ≥1.0 × 10^9/L (no G-CSF in past 7 days); hemoglobin >7.5 g/dL (blood transfusions allowed to maintain >7.5 g/dL); platelet count ≥75 × 10^9/L for subjects with <50% plasma cells in marrow, otherwise ≥50 × 10^9/L (no platelet transfusions in past 7 days)
Kidney function
Renal insufficiency: eGFR < 40 mL/min/1.73m^2 (based on MDRD formula) for Cohort A; exclusion if requires immediate treatment for renal failure (e.g., dialysis) until stable
Liver function
ALT <2.5 × ULN, AST <2.5 × ULN, total bilirubin <1.5 × ULN (except for Gilbert Syndrome: direct bilirubin <2 × ULN)
Cardiac function
No clinically significant cardiac disease (MI within 6 months, unstable angina, CHF NYHA III-IV, uncontrolled arrhythmia NCI-CTCAE v5 Grade 2+, QTcF >470 msec, uncontrolled hypertension)
Any of the following laboratory test results at the time of enrollment: Absolute neutrophil count <1.0 × 10^9/L; hemoglobin ≤7.5 g/dL; platelet count <75 × 10^9/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells; otherwise platelet count <50 × 10^9/L; ALT ≥2.5 × ULN; AST ≥2.5 × ULN; total bilirubin ≥1.5 × ULN, (except for Gilbert Syndrome: direct bilirubin ≥2 × ULN).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Froedtert Hospital & the Medical College of Wisconsin · Milwaukee, Wisconsin
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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